While novel oral anticoagulants demonstrate efficacy and safety in clinical trials, their successful implementation in routine practice requires addressing challenges related to real-world safety, monitoring, and reversibility.
Caution advised for dabigatran or rivaroxaban in vulnerable patients; leaves open need for real-world safety studies.
Vitamin K antagonists (VKA) are the only registered oral anticoagulants for the treatment of venous thromboembolism (VTE). VKA have an unpredictable and highly variable effect on coagulation, with a high risk of under- and over-treatment. Novel anticoagulants, such as dabigatran and rivaroxaban, could be a very welcome replacement for VKA, as they show a predictable anticoagulant effect. Results of several phase II and III studies have shown the efficacy and safety of dabigatran and rivaroxaban in the prophylaxis and treatment of VTE, and for the prevention of stroke in atrial fibrillation. It remains to be shown whether these new anticoagulants have the same safety profile in daily clinical practice, where more vulnerable patients will be treated. Lack of information on the proper monitoring method or antidote in case of bleeding may also hinder the translation from science to clinical practice.
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Eerenberg et al. (2011) studied this question.
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